Effects of Pilates Exercises Versus Walking on Mechanical and Vascular Variables of Individuals With Type 2 Diabetes Mellitus

NCT ID: NCT04732611

Last Updated: 2021-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-31
• Study Completion Date: 2022-08-31

Brief Summary

The Diabetes Mellitus (DM) is a major worldwide public health problem. The hyperglycemia resulting from DM could lead to metabolic adaptations and physiological changes in different body systems. The DM patients are usually sedentary, once the symptoms as the sensory deficits compromise balance and gait. Giving that this sedentary lifestyle needs to be reversed, since physical exercise is well known a fundamental element in the treatment and prevention of the DM.

The major recommendations to this population is the practice of aerobic exercises and the strength training focused on the biggest muscle groups. It is well know that this type of exercise can improve the uptake of intramuscular glucose. In that context the Pilates Method seems as a good option of exercise, once the method works in a global way, working on different muscle groups in the same exercise. Besides that, to the best of our knowledge there aren't enough studies to support the Pilates Method as an alternative type exercise to help in the glycemic control and in the management of this kind of patients. The aim of this study is to evaluate the efficacy and safety of an exercise program using the Pilates Method versus a walking program in neuromuscular, metabolic and vascular variables in type 2 diabetic patients.

60 participants will be recruited by convenience. Individuals will be eligible if [1] they had type 2 diabetes mellitus; [2] men and women aged 35 to 60 years [3] medical approval to practice exercise; [4] do not have any bone, joint or muscle disease that make the practice of exercises impossible; [5] not being pregnant; [6] not being unable to follow the instructions for any reason and [7] at least 6 months without exercising. The participants' eligibility will be checked by the researcher. Subsequently, they will be allocated randomly in one of the two groups (Pilates Group or Walking).

Pilates group participants will perform 3 Pilates sessions a week lasting approximately 50 minutes for 20 weeks. Walking group participants will perform 3 walking sessions a week lasting approximately 50 minutes for 20 weeks. All the exercises sessions will be supervised by a professional.

All the participants will be evaluated at the baseline and after 20 weeks of exercises. The main outcome of this study are the Triceps surae muscle force and the blood glycose. The secondary outcomes are Triceps surae muscle architecture, mechanical adaptations of the Achilles tendon and endothelial function.

Our hypothesis is that both groups will be safety and efficiency to improve the Triceps surae muscle force and to decrease blood glycose. Our secondary hypothesis is that the Pilates Group will show better results to both primary outcomes than the walking group.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Pilates

Pilates group participants will perform 3 weekly Pilates sessions lasting approximately 50 minutes for 20 weeks.

Group Type: EXPERIMENTAL

Pilates exercises

Intervention Type: OTHER

Pilates group participants will perform 3 weekly Pilates sessions lasting approximately 50 minutes for 20 weeks.

Walking

Walking group participants will perform 3 weekly walking sessions lasting approximately 50 minutes for 20 weeks

Group Type: ACTIVE_COMPARATOR

Walking protocol

Intervention Type: OTHER

Walking group participants will perform 3 weekly walking sessions lasting approximately 50 minutes for 20 weeks.

Interventions

Pilates exercises

Pilates group participants will perform 3 weekly Pilates sessions lasting approximately 50 minutes for 20 weeks.

Intervention Type: OTHER

Walking protocol

Walking group participants will perform 3 weekly walking sessions lasting approximately 50 minutes for 20 weeks.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Men and women between 35 and 65 years old;
• Possess type 2 diabetes mellitus diagnosed;
• Medical approval to practice exercise;
• Do not have any bone, joint or muscle disease that make impossible do the exercises;
• not being pregnant;
• not being unable to follow the instructions for any reason;
• not be exercising for at least 6 months.

Exclusion Criteria

• Incapacity to follow the instructions for any reason;
• Beginning another treatment for DM2, either physical therapy, exercises or changes of the medical care throughout the study period.
• Having practiced exercises in the last six months;
• Pregnancy;

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Rio Grande do Sul

OTHER

Sponsor Role: lead

Responsible Party

Jefferson Fagundes Loss

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jefferson F Loss, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul

Central Contacts

Edgar Santiago Wagner Neto, Ms

Role: CONTACT

edgar.swagner@gmail.com

+55 51 984419763

Jefferson F Loss, PhD

Role: CONTACT

jefferson.loss@ufrgs.br

+55 51 33085822

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Other Identifiers

39137

Identifier Type: -

Identifier Source: org_study_id